Famotidine Tablet
FDA Recall NDC 55111-396
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Famotidine (NDC 55111-396). A significant event, classified as Class III, was initiated on Oct 03, 2017 by Dr.reddys Laboratories Limited. The reported reason for this action was: "Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
October 2017 Class III Recall: Failed impurities/degradation specifications
Recall Number
Class III Terminated
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Oct 03, 2017
Oct 18, 2017
569376 bottles
Recall Profile & Regulatory Data
Event ID
78220
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 15, 2019
Product Description
Famotidine tablets, 10 mg, packaged in 30-count bottle, OTC, labeled as a) CVS Pharmacy Acid Controller, NDC 55111-118-30, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, b) Equate Famotidine, NDC 49035-118-30, Distributed by: Wal-Mart Stores, Inc. Bentonville, AR 72716, Made in India
Batch or Lot Expiration Information
Lot# : a) 79C408882B, 79C408884C, 79C408886B, Exp 10/17; 79C501523B, Exp 01/18; 79C501524B, Exp 01/18; 79C502318B, Exp 3/18; b) 79C408885B, 79C408886A, Exp 10/17; 79C500967, 79C501523C, 79C501525A, 79C501525B, 79C501525C, 79C501526B, Exp 01/18; 79C502317A, Exp 3/18; 79C504087B, 79C504088A, Exp 5/18; 79C505926A, Exp 7/18.
Affected Packages Involved in this Recall
55111-118-30Product
55111-118-40Product
55111-118-60Product
55111-118-90Product
55111-118-04Product
55111-118-18Product
55111-118-24Product
55111-118-35Product
55111-118-81Product
55111-118-79Product
55111-118-12Product
55111-396-35Product
55111-396-50Product
55111-396-65Product
55111-396-90Product
55111-396-44Product
55111-396-01Product
55111-396-13Product
55111-396-32Product
55111-396-08Product
55111-396-16Product
49035-118-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
